Acute Myocardial InfarctionNCT05404555
Prognostic Value of Right Ventricular Myocardial Strain in Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Peking University Third Hospital at 1 site in China.
Trial summary
For a long time, the right ventricle has been the "forgotten chamber", but with the deepening of people's understanding of the disease, right ventricular dysfunction has become an important factor to evaluate the disease progression and late prognosis of patients with AMI. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- two-dimensional speckle tracking echocardiography
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute myocardial infarction undergoing primary percutaneous coronary intervention are included.
Who may be able to join
- Males and females were between 35 and 85 years old;
- coronary artery disease underwent emergency PCI for NSTEMI or primary PCI for STEMI;
- coronary artery type was right coronary dominance;
- regular follow-up for 2 year.
Who cannot join
- Patients who cannot complete 2D speckle tracking imaging;
- patients with severe valvular disease, cardiomyopathy, or congenital heart disease; severe liver and kidney insufficiency or chronic respiratory disease;
- previous PCI or CABG;
- coronary artery type: Left crown dominance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Guisong Wang, doctor, 13701070359, guisongwang@bjmu.edu.cn
Pengqiang Li, doctor, 18535915565, Simon18535915565@163.com
About this study
Official title: Prognostic Value of Right Ventricular Myocardial Strain in Patients With Acute Myocardial Infarction With Different Infarction-related Vessels
For a long time, the right ventricle has been the "forgotten chamber", but with the deepening of people's understanding of the disease, right ventricular dysfunction has become an important factor to evaluate the disease progression and late prognosis of patients with AMI. Right ventricular myocardial strain derived from two-dimensional speckle tracking echocardiography is a new method for early evaluation of regional and global right ventricular systolic function, and its repeatability is much higher than that of LVEF. Acute inferior myocardial infarction is often caused by occlusion of the proximal middle segment of the right coronary artery. Many studies have confirmed that RVMS is an independent predictor of poor prognosis in patients with AIMI. However, 60% of the right ventricular systolic function is contributed by the left ventricle and interventricular septum, and the left anterior descending branch and the left circumflex branch are the main sources of blood supply to the left ventricle and interventricular septum, so in theory, non-RCA occlusion can also lead to varying degrees of right ventricular dysfunction. However, there are few studies on the role of RVMS in predicting the prognosis of AMI patients caused by non-RCA occlusion. Therefore, the purpose of this study is to prospectively study the value of dynamic changes of RVMS in predicting the prognosis of patients with acute myocardial infarction with different infarct-related vessels, in order to provide more clinical reference information for the diagnosis and treatment of AMI.
Read the detailed description
In this study, 200 patients with acute myocardial infarction treated in Peking University Third Hospital from March 2022 to March 2024 were enrolled in this study. the parameters of myocardial enzymes, blood lipids and echocardiography were collected at the acute stage, 2 weeks and 6 months after discharge, and were followed up for two year. The echocardiographic parameters and MACE of patients with acute myocardial infarction with different infarction related vessels were compared. This shows the significance of right ventricular myocardial strain in predicting the prognosis of patients with acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- two-dimensional speckle tracking echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional speckle tracking echocardiographyOther
Two-dimensional speckle tracking echocardiography is used to assess cardiac function in all enrolled patients
| Study group | Role | What they receive |
|---|---|---|
| acute myocardia infarction patients with right coronary artery occlusion | Not described Receives: Other: two-dimensional speckle tracking echocardiography | |
| acute myocardia infarction patients with non-right coronary artery occlusion | Not described Receives: Other: two-dimensional speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Nonfatal stroke, nonfatal myocardial infarction, target vessel requiring revascularization, death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Oct 2021
- Primary completion30 May 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404555
- Sponsor's protocol ID
- M2022093
- Status last verified
- Mar 2022
- First submitted
- 31 May 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Right Ventricular Myocardial Strain in Patients With Acute Myocardial Infarction With Different Infarction-related Vessels
- ClinicalTrials.gov ID
- NCT05404555
- Acronym / sponsor ID
- M2022093
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For a long time, the right ventricle has been the "forgotten chamber", but with the deepening of people's understanding of the disease, right ventricular dysfunction has become an important factor to evaluate the disease progression and late prognosis of patients with AMI. Right ventricular myocardial strain derived from two-dimensional speckle tracking echocardiography is a new method for early evaluation of regional and global right ventricular systolic function, and its repeatability is much higher than that of LVEF. Acute inferior myocardial infarction is often caused by occlusion of the proximal middle segment of the right coronary artery. Many studies have confirmed that RVMS is an independent predictor of poor prognosis in patients with AIMI. However, 60% of the right ventricular systolic function is contributed by the left ventricle and interventricular septum, and the left anterior descending branch and the left circumflex branch are the main sources of blood supply to the left ventricle and interventricular septum, so in theory, non-RCA occlusion can also lead to varying degrees of right ventricular dysfunction. However, there are few studies on the role of RVMS in predicting the prognosis of AMI patients caused by non-RCA occlusion. Therefore, the purpose of this study is to prospectively study the value of dynamic changes of RVMS in predicting the prognosis of patients with acute myocardial infarction with different infarct-related vessels, in order to provide more clinical reference information for the diagnosis and treatment of AMI.
Detailed description
In this study, 200 patients with acute myocardial infarction treated in Peking University Third Hospital from March 2022 to March 2024 were enrolled in this study. the parameters of myocardial enzymes, blood lipids and echocardiography were collected at the acute stage, 2 weeks and 6 months after discharge, and were followed up for two year. The echocardiographic parameters and MACE of patients with acute myocardial infarction with different infarction related vessels were compared. This shows the significance of right ventricular myocardial strain in predicting the prognosis of patients with acute myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute myocardia infarction patients with right coronary artery occlusion | – | Other: two-dimensional speckle tracking echocardiography |
| acute myocardia infarction patients with non-right coronary artery occlusion | – | Other: two-dimensional speckle tracking echocardiography |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute myocardial infarction undergoing primary percutaneous coronary intervention are included.
Key inclusion criteria (4 listed)
- Males and females were between 35 and 85 years old;
- coronary artery disease underwent emergency PCI for NSTEMI or primary PCI for STEMI;
- coronary artery type was right coronary dominance;
- regular follow-up for 2 year.
Key exclusion criteria (4 listed)
- Patients who cannot complete 2D speckle tracking imaging;
- patients with severe valvular disease, cardiomyopathy, or congenital heart disease; severe liver and kidney insufficiency or chronic respiratory disease;
- previous PCI or CABG;
- coronary artery type: Left crown dominance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two-dimensional speckle tracking echocardiographyTwo-dimensional speckle tracking echocardiography is used to assess cardiac function in all enrolled patients | Other | acute myocardia infarction patients with non-right coronary artery occlusion, acute myocardia infarction patients with right coronary artery occlusion |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 2 years
Nonfatal stroke, nonfatal myocardial infarction, target vessel requiring revascularization, death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.